NEWS HIGHLIGHTS
Published Studies Related to Focalin (Dexmethylphenidate)
Long-term effectiveness and safety of dexmethylphenidate extended-release capsules in adult ADHD. [2009.03]
CONCLUSION: Once-daily d-MPH-ER 20 to 40 mg is safe and effective for long-term treatment of adult ADHD.
Double-blind, randomized trial of dexmethylphenidate hydrochloride for the treatment of sarcoidosis-associated fatigue. [2008.05]
BACKGROUND: Fatigue is a common complaint in patients with sarcoidosis. We studied the effectiveness of dexmethylphenidate hydrochloride (d-MPH) in treating sarcoidosis-associated fatigue... CONCLUSIONS: Treatment with d-MPH was associated with a significant improvement in sarcoidosis-associated fatigue. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT00361387.
Double-blind, randomized trial of dexmethylphenidate hydrochloride for the treatment of Sarcoidosis Associated Fatigue. [2008.02.08]
Background Fatigue is a common complaint in sarcoidosis... Conclusions Treatment with d-MPH was associated with a significant improvement in sarcoidosis associated fatigue.
Similar bioavailability of dexmethylphenidate extended (bimodal) release, dexmethyl-phenidate immediate release and racemic methylphenidate extended (bimodal) release formulations in man. [2007.12]
OBJECTIVE: The d-isomer of methylphenidate (d-MPH) is the pharmacologically active part of the racemic mixture of methylphenidate (d,l-MPH), which has been used for decades in the treatment of attention-deficit/hyperactivity disorder (ADHD). A modified release formulation with bimodal release for the pure d-enantiomer (Focalin XR) has been developed to enable a fast onset of action and a sustained activity for once-daily administration. It was intended to achieve a bimodal concentration-time profile as observed after administration of two immediate release Focalin tablets. The pharmacokinetics of this d-MPH bimodal release formulation were compared with a d-MPH immediate release formulation and a similar bimodal release formulation of d,l-MPH in healthy adult volunteers... CONCLUSIONS: In summary, the 20 mg extended (bimodal) release formulation of d-MPH (Focalin XR) demonstrated a bimodal concentration-time profile and was bioequivalent to two 10 mg doses of immediate release d-MPH (Focalin) and was bioequivalent to 40 mg extended (bimodal) release d,l-MPH (Ritalin LA).
A double-blind, placebo-controlled trial of dexmethylphenidate hydrochloride and d,l-threo-methylphenidate hydrochloride in children with attention-deficit/hyperactivity disorder. [2004.11]
CONCLUSIONS: For the treatment of ADHD, an average titrated dose of 18.25 mg/day of d-MPH is as efficacious and safe as an average titrated dose of 32.14 mg/day of d,l-MPH. Both active treatments have large effect sizes. Thus, d-MPH and d,l-MPH appear to provide similar efficacy, and d-MPH may have longer duration of action after twice-daily dosing, but additional studies are needed to determine the statistical and clinical significance of this possibility.
Clinical Trials Related to Focalin (Dexmethylphenidate)
Study of Dopamine Transporter Receptor Occupancy With Long-Acting Dex-Methylphenidate [Active, not recruiting]
The objectives of this study are to document the pharmacokinetics of the adequacy of DAT
receptor occupancy d-MPH formulation in three doses (20 mg, 30 mg, and 40 mg) using PET
scanning with C-11 Altropane as the ligand across a range of times. It has been estimated
that MPH is effective when the average CNS DAT occupancy is 50% or greater. Focalin XR has
been shown to be clinically effective in an analog classroom as early as 1 hour and as late
as 12 hours. Therefore, it is hypothesized that the average DAT occupancy will be adequate
(50% or greater) at time periods corresponding to the times of clinical efficacy.
The first objective is to examine the onset of action by testing whether average DAT
occupancy will be adequate (50% or greater) at 1 hour after dosing for each dose tested (20
mg, 30 mg, 40 mg).
The second objective is to test the adequacy of average DAT occupancy in a range of later
times for each dose. The times chosen (8, 10 and 12 hours) correspond to times Focalin XR has
been shown to be clinically effective in an analogue classroom study. A range of times have
been chosen since, while effective at 12 hours, the degree of clinical effectiveness
decreased with later time periods. The adequacy of DAT occupancy across this range of time
periods will provide important details on the in vivo molecular action of the medicine at
periods of critical clinical activity.
The third exploratory objective is to examine a time period later then those previously
tested with the highest dose. Since the clinical effectiveness of Focalin XR has not been
tested out to 14 hours, it is unknown whether it is effective at 14 hours. If Focalin XR were
to be effective at 14 hours it would be more likely at the highest dose.
D-MPH in the Treatment of Fatigue and Neurobehavioral Function Related to Chemotherapy in Adult Cancer Patients [Completed]
Efficacy, Tolerability and Safety of Dexmethylphenidate HCl Extended-Release Capsules in Children With Attention-Deficit/Hyperactivity Disorder [Completed]
The purpose of this study is to determine which dosages of dexmethylphenidate HCl
extended-release capsules may represent effective treatment for ADHD in children 6-12 years
of age.
Efficacy and Safety of Dex-Methylphenidate Extended Release 20 mg Versus Placebo in Children (6-12 Years) With Attention-Deficit/Hyperactivity Disorder (ADHD) in a Laboratory Classroom Setting [Completed]
This study will confirm the efficacy of dex-methylphenidate extended release 20 mg versus
placebo during an 8-hour laboratory classroom day.
Safety and Efficacy Study of Dexmethylphenidate in Children With ADHD [Completed]
The purpose of this study is to compare the safety and efficacy of two doses of
dexmethylphenidate to two doses of an approved, long-acting, marketed medication for ADHD
(MPH) and placebo in children ages 6-12 diagnosed with ADHD.
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